This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method,and investigate its widespread use in patients,in order to regulate and ...This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method,and investigate its widespread use in patients,in order to regulate and guide the rational drug use,improve the drug specificity and provide a basis for drug therapy.The study adopts a prospective,multi-center,large sample size,centralized hospital monitoring system.We selected five leading hospitals in Hubei province,and observed the inpatients who received the ornidazole injection from July 1,2015 to October 31,2015.The basic information of patients was recorded,as well as the drug use and adverse events.The statistical analysis was performed based on these data.A total of 4396 individuals were enrolled in this study,most of them were middle-aged female patients and the ornidazole injection was mainly used as prophylactic prior to surgery to prevent the infections,and surgical treatment of anaerobic infections,abdominal infections and pelvic infections.The irrational drug use existed mainly in the prescribing and administration process,including unreasonable dosing frequency,rapid intravenous drip speed and extended duration of drug use.Eleven cases of adverse reactions were collected during the monitoring,incidence rate of adverse reactions was 2.5‰;adverse drug reactions occurred within 30 min.The study results fully reflected the usage of ornidazole injection in the real world.Based on the study,we calculated the adverse reaction incidence of ornidazole and identified the risk factors which may affect the safety of ornidazole injection.Study results strongly recommend that the manufacturers should publish standards for inpatient use and doctors should prescribe with caution accordingly.展开更多
The deep and confined Maastrichtian aquifer contains considerable groundwater resources. It stretches over nearly 200,000 km2, from the northern part of Mauritania to the South of Guinea Bissau where it becomes shallo...The deep and confined Maastrichtian aquifer contains considerable groundwater resources. It stretches over nearly 200,000 km2, from the northern part of Mauritania to the South of Guinea Bissau where it becomes shallow. The reservoir is composed mainly of coarse sands and sandstone interbedded with some clay units. The aquifer provides 40% of the total drinking water extracted from the different aquifers and nearly 800 wells equally distributed operate only in the top 50 m of the aquifer. Despite the importance of these resources for providing water in the rural and urban areas, the aquifer characteristics are not well defined. The present paper aims to define first the physical and chemical characteristics of the Maastrichtian aquifer. The reserve of the aquifer initially estimated at 350 billion m3, is reassessed using new data providing from cross sections realized as part of our research, through the Water Sectorial Project of the Ministry of Hydraulics. Data from oil wells and geophysical logging are used to investigate the geometry of the aquifer and the position of the fresh/salty water interface. The highest thickness of the aquifer is between 200 to 400 m and salty water is present below the fresh groundwater in the west side of the aquifer. In the Eastern side, potable water lies directly above the basement. The thickness of the aquifer increases from the west to the center, and then decreases towards the shallow basement rock in the South East. The average thickness is 250 m. Chemical data coming from pumping wells indicate high chloride (250 - 1600 mg/l) and fluoride content (1 - 5.5 mg/l). Therefore, the reassessment has to take into account the chemical aspect of the water.展开更多
The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisa...The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine.In this paper,we propose a reappraisal protocol called“precise proprietary Chinese medicine”to precisely i)define the therapeutic aim;ii)design the protocol;iii)control the quality of proprietary Chinese medicine;iv)implement the protocol in the trial;v)study the mechanism-of-action of the proprietary Chinese medicine and vi)describe the indications of the proprietary Chinese medicine.We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.展开更多
Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine ...Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be considered an important therapeutic option in the diabetic patients.展开更多
CHINA＇S economic growth slipped to 7.4 percent in the first quarter, signaling more downward pres-sure for the world＇s second largest economy, However. authorities have ruled out the possibility of major stimulus to...CHINA＇S economic growth slipped to 7.4 percent in the first quarter, signaling more downward pres-sure for the world＇s second largest economy, However. authorities have ruled out the possibility of major stimulus to fight short-term dips in growth and plan to seek growth momentum through deep-seated reforms and reinvigorated domestic consumption.展开更多
The aim of this study was to describe the characteristics of patients with deep vein thrombosis (DVT) of the pelvic limbs at the time of diagnosis, and their course after hospitalization, in order to improve the manag...The aim of this study was to describe the characteristics of patients with deep vein thrombosis (DVT) of the pelvic limbs at the time of diagnosis, and their course after hospitalization, in order to improve the management of DVT in our context. This was a descriptive longitudinal study, based on cases of deep vein thrombosis recorded between 1 January 2015 and 30 September 2018, in the cardiology and internal medicine department of the Brazzaville University Hospital Centre. During the study period, 4678 patients were hospitalized, including 52 with DVT. Thirty-three were reassessed. The frequency of DVT was 1.1% and the average hospitalization rate was 13.9 cases/year. The 33 patients were divided into 20 women and 13 men (sex ratio: 0.65). The mean age of the patients was 51.4 ± 17.8 years (extremes: 16 and 85 years). The main aetiological factors were cancer (19.1%), sickle cell disease (3%) and HIV immunosuppression (3%). The predominant risk factors were: prolonged immobilization (42.9%), pregnancy, long travel and obesity in the same number of cases (n = 3, i.e. 14.2%). The DVT involved the left pelvic limb in 75.8% of cases. Anticoagulants were administered in all patients, and compression stockings were worn in 97% of cases. The mean time to re-evaluation was 10.9 ± 9.4 months (extremes: three and 35 months). The mean measurements of the limb where the thrombosis had occurred at diagnosis and reassessment showed a significant difference. Venous Doppler showed compressible veins (60.6%), varicosities (36.3%), incompressible veins (30.3%) and thrombus (21.2%). Complications were: post-phlebitic disease (42.4%), death (21.2%), pulmonary embolism (18.2%), recurrence (18.2%). The DVT remains relatively rare, and its conventional therapeutic management is satisfactory. Systematic venous Doppler ultrasound reassessment should enable patients at risk of recurrence to be identified.展开更多
Andrographolide total ester sulfonate（ATES） injection is one of the products of traditional Chinese medicine（TCM） currently used against viral infection in China.ATES injection was approved for manufacturing and m...Andrographolide total ester sulfonate（ATES） injection is one of the products of traditional Chinese medicine（TCM） currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-world clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86% were contraindicated.Irregular medication of adults and children accounted for 1.91% and 23.38%,respectively.Improper choice of solvent accounted for 3.18%.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events（AEs） was observed in the monitoring period,and the incidence of adverse drug reaction（ADR） of ATES injection was 0.12%.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.展开更多
文摘This study aims to analyze the clinical use of ornidazole injection at the post-marketing stage by centralized hospital monitoring system method,and investigate its widespread use in patients,in order to regulate and guide the rational drug use,improve the drug specificity and provide a basis for drug therapy.The study adopts a prospective,multi-center,large sample size,centralized hospital monitoring system.We selected five leading hospitals in Hubei province,and observed the inpatients who received the ornidazole injection from July 1,2015 to October 31,2015.The basic information of patients was recorded,as well as the drug use and adverse events.The statistical analysis was performed based on these data.A total of 4396 individuals were enrolled in this study,most of them were middle-aged female patients and the ornidazole injection was mainly used as prophylactic prior to surgery to prevent the infections,and surgical treatment of anaerobic infections,abdominal infections and pelvic infections.The irrational drug use existed mainly in the prescribing and administration process,including unreasonable dosing frequency,rapid intravenous drip speed and extended duration of drug use.Eleven cases of adverse reactions were collected during the monitoring,incidence rate of adverse reactions was 2.5‰;adverse drug reactions occurred within 30 min.The study results fully reflected the usage of ornidazole injection in the real world.Based on the study,we calculated the adverse reaction incidence of ornidazole and identified the risk factors which may affect the safety of ornidazole injection.Study results strongly recommend that the manufacturers should publish standards for inpatient use and doctors should prescribe with caution accordingly.
文摘The deep and confined Maastrichtian aquifer contains considerable groundwater resources. It stretches over nearly 200,000 km2, from the northern part of Mauritania to the South of Guinea Bissau where it becomes shallow. The reservoir is composed mainly of coarse sands and sandstone interbedded with some clay units. The aquifer provides 40% of the total drinking water extracted from the different aquifers and nearly 800 wells equally distributed operate only in the top 50 m of the aquifer. Despite the importance of these resources for providing water in the rural and urban areas, the aquifer characteristics are not well defined. The present paper aims to define first the physical and chemical characteristics of the Maastrichtian aquifer. The reserve of the aquifer initially estimated at 350 billion m3, is reassessed using new data providing from cross sections realized as part of our research, through the Water Sectorial Project of the Ministry of Hydraulics. Data from oil wells and geophysical logging are used to investigate the geometry of the aquifer and the position of the fresh/salty water interface. The highest thickness of the aquifer is between 200 to 400 m and salty water is present below the fresh groundwater in the west side of the aquifer. In the Eastern side, potable water lies directly above the basement. The thickness of the aquifer increases from the west to the center, and then decreases towards the shallow basement rock in the South East. The average thickness is 250 m. Chemical data coming from pumping wells indicate high chloride (250 - 1600 mg/l) and fluoride content (1 - 5.5 mg/l). Therefore, the reassessment has to take into account the chemical aspect of the water.
文摘The clinical efficacy and safety of proprietary Chinese medicine has become a more prevailing public health concern.The China Food and Drug Administration has pushed drug companies to conduct post-marketing reappraisal for proprietary Chinese medicine to provide additional evidence supporting the efficacy and safety of these medicine.In this paper,we propose a reappraisal protocol called“precise proprietary Chinese medicine”to precisely i)define the therapeutic aim;ii)design the protocol;iii)control the quality of proprietary Chinese medicine;iv)implement the protocol in the trial;v)study the mechanism-of-action of the proprietary Chinese medicine and vi)describe the indications of the proprietary Chinese medicine.We hope that these steps facilitate the post-marketing reappraisal of proprietary Chinese medicine.
文摘Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be considered an important therapeutic option in the diabetic patients.
文摘CHINA＇S economic growth slipped to 7.4 percent in the first quarter, signaling more downward pres-sure for the world＇s second largest economy, However. authorities have ruled out the possibility of major stimulus to fight short-term dips in growth and plan to seek growth momentum through deep-seated reforms and reinvigorated domestic consumption.
文摘The aim of this study was to describe the characteristics of patients with deep vein thrombosis (DVT) of the pelvic limbs at the time of diagnosis, and their course after hospitalization, in order to improve the management of DVT in our context. This was a descriptive longitudinal study, based on cases of deep vein thrombosis recorded between 1 January 2015 and 30 September 2018, in the cardiology and internal medicine department of the Brazzaville University Hospital Centre. During the study period, 4678 patients were hospitalized, including 52 with DVT. Thirty-three were reassessed. The frequency of DVT was 1.1% and the average hospitalization rate was 13.9 cases/year. The 33 patients were divided into 20 women and 13 men (sex ratio: 0.65). The mean age of the patients was 51.4 ± 17.8 years (extremes: 16 and 85 years). The main aetiological factors were cancer (19.1%), sickle cell disease (3%) and HIV immunosuppression (3%). The predominant risk factors were: prolonged immobilization (42.9%), pregnancy, long travel and obesity in the same number of cases (n = 3, i.e. 14.2%). The DVT involved the left pelvic limb in 75.8% of cases. Anticoagulants were administered in all patients, and compression stockings were worn in 97% of cases. The mean time to re-evaluation was 10.9 ± 9.4 months (extremes: three and 35 months). The mean measurements of the limb where the thrombosis had occurred at diagnosis and reassessment showed a significant difference. Venous Doppler showed compressible veins (60.6%), varicosities (36.3%), incompressible veins (30.3%) and thrombus (21.2%). Complications were: post-phlebitic disease (42.4%), death (21.2%), pulmonary embolism (18.2%), recurrence (18.2%). The DVT remains relatively rare, and its conventional therapeutic management is satisfactory. Systematic venous Doppler ultrasound reassessment should enable patients at risk of recurrence to be identified.
基金supported by the Guangdong Pharmacological Society of China(No.2009ZX09502-030)
文摘Andrographolide total ester sulfonate（ATES） injection is one of the products of traditional Chinese medicine（TCM） currently used against viral infection in China.ATES injection was approved for manufacturing and marketing in January 2002.It is indicated for acute respiratory infections,tonsillitis,chronic obstructive pulmonary disease,influenza,foot and mouth disease,bronchiolitis,herpangina,mumps,infectious mononucleosis and psychosis.However,its usage also carries risk.We investigated the use of ATES at the Wuhan Union Hospital from January 2014 to December 2014 and evaluated its real-world clinical application using the hospital centralized monitoring method.A total of 848 cases were enrolled in this study.In these cases,it was mainly used for postoperative anti-inflammation and treating upper respiratory infection,pneumonia and bronchitis.Among them,39.86% were contraindicated.Irregular medication of adults and children accounted for 1.91% and 23.38%,respectively.Improper choice of solvent accounted for 3.18%.The choice of intravenous drip versus aerosol inhalation was reasonable.A case of adverse events（AEs） was observed in the monitoring period,and the incidence of adverse drug reaction（ADR） of ATES injection was 0.12%.ATES injection in our hospital is relatively safe with a low incidence of adverse reactions.The study assesses the clinical usage and adverse reactions of ATES injection,and provides suggestions for rational use in clinical practice.
